Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 (EV-006)

A Multi-center, Open Label, Single Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines

The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adult subjects.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: DWP-450 (Botulinum purified neurotoxin, Type A)

Detailed Description

Up to five hundred and thirty (530) subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study.

Subjects with moderate-to-severe glabellar lines at maximum frown on the 4 point Glabellar Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will be eligible for injection with DWP-450.

Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.

• Study Type: Interventional
• Enrollment (Actual): 570
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • The Advanced Skin Research Center at Skin Specialists, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be an adult 18 years of age and over
• Subject is able to provide informed consent and comply with study instructions
• Subject has moderate-to-severe glabellar lines on maximum frown as assessed by the investigator and subject using the GLS
• Subject is willing and able to complete the entire course of the study

Exclusion Criteria:

• Previous treatment with botulinum toxin of any serotype in any area within the last 6 months
• Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
• Previous insertion of permanent material in the glabellar area
• Planned treatment with botulinum toxin of any serotype in any other body region during the study period
• Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
• Energy based or cryo-therapy based treatment of facial muscles superior to the lateral canthus
• Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine)
• Inability to substantially lessen glabellar frown lines even by physically spreading them apart
• Marked facial asymmetry
• Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis
• History of facial nerve palsy
• Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
• Any active infection in the area of the injection sites
• Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
• Evidence of recent alcohol or drug abuse
• Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
• Pregnant, nursing or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
• Known allergy or hypersensitivity to botulinum toxin preparation
• Participation in another interventional clinical study within the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum toxin, Tyoe A; DWP-450 (Botulinum toxin, Type A)	Biological: DWP-450 (Botulinum purified neurotoxin, Type A); Botulinum toxin, Type A; Other Names: DWP-450

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year	The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.	365 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown	Proportion of subjects with an improvement of 1 point or more (i.e., ≥1 point responders) on the GLS at rest at end of study/early termination: by Investigator assessment	365 days

Collaborators and Investigators

• Sponsor: Evolus, Inc.
• Collaborators: PPD
• Investigators: Study Director: Rui Avelar, MD, Evolus, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Glabellar Lines; Botulinum toxin, Type A
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A
• Other Study ID Numbers: Evolus - CLIN006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Developing a plan